Duns Number:264255288
Device Description: Nexis Ø3,7 counterboring for compressive PECA screw
Catalog Number
XRE01023
Brand Name
NEXIS
Version/Model Number
XRE01023
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143229
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
3c44257a-38ef-4b73-bdb4-a370ea03d407
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |